Table 4.
Descriptions of main Sicilian ADRs associated with TKIs for NSCLC treatment and reported into the RNF.
| Adverse Drug Reaction, n (%) | EGFRi | ALKi | VEGFi | Total (n = 263) | |||||
|---|---|---|---|---|---|---|---|---|---|
| AFT (n = 42) | ERL (n = 138) | GEF (n = 46) | OSI (n = 12) | ALEC (n = 1) | CER (n = 3) | CRIZ (n = 16) | NTB (n = 5) | ||
| Skin and subcutaneous tissue disorders | 25 (59.5) | 86 (62.3) | 15 (32.6) | 4 (33.3) | 2 (12.5) | 132 | |||
| Rash | 15 (35.7) | 42 (30.4) | 9 (19.6) | 4 (33.3) | 1 (6.3) | 71 | |||
| Pruritus | 3 (7.1) | 13 (9.4) | 3 (6.5) | 19 | |||||
| Nail and nail bed conditions | 4 (9.5) | 7 (5.1) | 6 (13.0) | 1 (8.3) | 18 | ||||
| Gastrointestinal disorders | 24 (57.1) | 25 (18.1) | 12 (26.1) | 4 (33.3) | 1 (33.3) | 2 (12.5) | 4 (80.0) | 72 | |
| Diarrhea | 20 (47.6) | 19 (13.8) | 11 (23.9) | 4 (33.3) | 3 (60.0) | 57 | |||
| Vomiting | 1 (2.4) | 3 (2.2) | 1 (2.2) | 1 (6.3) | 1 (20.0) | 7 | |||
| Abdominal pain | 2 (1.4) | 1 (2.2) | 1 (8.3) | 1 (33.3) | 1 (6.3) | 6 | |||
| General disorders and administration site conditions | 6 (14.3) | 32 (23.2) | 5 (10.9) | 3 (25.0) | 4 (25.0) | 1 (20.0) | 51 | ||
| Asthenia | 1 (2.4) | 12 (8.7) | 4 (8.7) | 1 (8.3) | 2 (12.5) | 1 (20.0) | 21 | ||
| Xerosis | 12 (8.7) | 12 | |||||||
| Mucosal inflammation | 3 (7.1) | 2 (1.4) | 5 | ||||||
| Infections and infestations | 3 (7.1) | 22 (15.9) | 3 (6.5) | 28 | |||||
| Conjunctivitis | 3 (7.1) | 11 (8.0) | 1 (2.2) | 15 | |||||
| Folliculitis | 12 (8.7) | 1 (2.2) | 13 | ||||||
| Hepatobiliary disorders | 1 (2.4) | 03 (2.2) | 15 (32.6) | 1 (33.3) | 8 (50.0) | 1 (20.0) | 29 | ||
| Hypertransaminasaemia | 1 (2.4) | 1 (0.7) | 14 (30.4) | 1 (33.3) | 8 (50.0) | 1 (20.0) | 26 | ||
| Respiratory, thoracic and mediastinal disorders | 4 (9.5) | 17 (12.3) | 1 (2.2) | 22 | |||||
| Dyspnoea | 7 (5.1) | 7 | |||||||
| Respiratory failure | 1 (2.4) | 6 (4.3) | 7 | ||||||
| Blood and lymphatic system disorders | 1 (2.4) | 7 (5.1) | 1 (2.2) | 4 (33.3) | 13 | ||||
| Anaemia | 1 (2.4) | 2 (1.4) | 1 (2.2) | 1 (8.3) | 5 | ||||
| Metabolism and nutrition disorders | 1 (2.4) | 6 (4.3) | 5 (10.9) | 12 | |||||
| Decreased appetite | 1 (2.4) | 6 (4.3) | 7 | ||||||
| Eye disorders | 4 (9.5) | 3 (2.2) | 3 (18.8) | 10 | |||||
| Eye oedema | 2 (12.5) | 2 | |||||||
| Growth of eyelashes | 2 (1.4) | 2 | |||||||
| Ocular hyperaemia | 1 (2.4) | 1 (6.3) | 2 | ||||||
| Cardiac disorders | 2 (1.4) | 2 (66.7) | 5 (31.3) | 9 | |||||
| Bradycardia | 2 (66.7) | 3 (18.8) | 5 | ||||||
| Reproductive system and breast disorders | 1 (100) | 1 | |||||||
| Peyronie’s disease | 1 (100) | 1 | |||||||
Bold type intended as System Organ Classes. ADR, adverse drug reaction; AFT, afatinib; ALEC, alectinib; ALKi, anaplastic lymphoma kinase inhibitors; CER, ceritinib; CRIZ, crizotinib; EGFRi, epidermal growth factor receptor inhibitors; ERL, erlotinib; GEF, gefitinib; NSCLC, non-small cell lung cancer; NTB, nintedanib; OSI, osimertinib; TKIs, tyrosine kinase inhibitors; VEGFi, vascular endothelial growth factor inhibitor; RNF, Rete Nazionale di Farmacovigilanza.